Trial begins for first artificial liver device using human cells

February 25, 1999

Physicians at the University of Chicago Hospitals are beginning clinical testing of the first artificial liver device that uses cells from humans rather than from pigs. The ELAD (extracorporeal liver assist device), produced by Vitagen Incorporated of La Jolla, California, is designed to serve as a temporary liver support for patients with acute liver failure, keeping them alive until their own organ can recover or until a suitable organ becomes available for transplantation.

As the pilot center for the first controlled trial of the device, the University of Chicago is the only hospital in the world currently able to offer this treatment.

"Other sources' liver assist devices have produced encouraging results," said Michael Millis, MD, associate professor of surgery and director of the liver transplant program at the University of Chicago Hospitals, "but there has been a good deal of concern about exposing patients to animal cells, which may function slightly differently and could harbor infectious agents. This trial should determine whether a device that incorporates human rather than pig-liver cells can reduce those risks and perhaps function more like a normal human organ."

A second advantage is that this device is designed to be used continuously for up to 10 days. At present, other artificial liver devices containing pig cells can be used for no more than six to eight hours each day.

The study will involve patients with fulminant hepatic failure (FHF), a rapidly worsening liver dysfunction that primarily occurs in young, healthy people. Although the cause is often unknown, FHF can result from viral liver infections, exposure to particular toxins, or to certain drugs, such as an overdose of acetaminophen. FHF can cause multi-organ failure, brain damage, and death. The natural history of this disease--from normal health to early symptoms, such as jaundice and fatigue, to coma and death--is often measured in days; at most a few weeks.

The primary goal of the ELAD Artificial Liver is to support the patient through a brief period of liver failure, protecting the brain and other organs for up to 10 days, and to give the damaged liver time to recover without transplantation.

The secondary goal is to extend the patient's ability to survive awaiting a suitable organ for transplant. Patients in complete liver failure have only a few days to wait before irreversible damage begins. With more than 12,000 people currently waiting for a liver transplant and fewer than 4,500 viable livers donated each year, there is no guarantee that a suitable organ will become available in time. In 1997, a total of 1,131 patients died while waiting for a liver transplant.

The ELAD Artificial Liver may also be used to support a patient after transplantation until the grafted liver begins functioning adequately and can fully sustain the patient.

"This device has the potential to reduce the need for liver transplants by giving acutely ill patients with limited liver damage time to recover," said Dr. Millis. "It could also open the window of opportunity a little wider for those who absolutely need a new organ to survive."

The first patient enrolled in the trial was Sheryl Orlyk, 34, of Carpentersville, Illinois. She was hospitalized Friday, April 30, 1999 for sudden liver failure and transferred in critical condition to the University of Chicago Hospitals that Sunday afternoon for transplantation. She was connected to the ELAD at 11:50 pm on Sunday, which appeared to halt her rapid decline. Fortunately a donor organ became available, and she was transplanted on Tuesday, May 4, 1999. She recovered quickly and was discharged from the hospital within 10 days.

The portable device uses a two-chambered, hollow-fiber cartridge filled with immortalized liver cells. The cell-filled cartridges, which can be installed in a kidney-dialysis-like machine, are stored at the Vitagen manufacturing facility in San Diego, California. They will be chilled to four degrees centigrade (about 40 degrees Fahrenheit) and flown to Chicago--like a "regular" organ--within hours of the request.

The system separates the plasma from the cellular components of the blood and pumps the patient's plasma through the cell-filled cartridges. These cartridges bring the plasma in contact with millions of metabolically active liver cells, which should function much like a normal liver. The treated plasma is then filtered, re-mixed with the cellular components of the blood, and returned to the patient.

The trial will involve 24 patients. The first six to enter the study will receive standard therapy plus treatment with the ELAD Artificial Liver. The next 18 patients will be divided randomly--nine to receive the treatment and nine to receive standard therapy.